| CTRI Number |
CTRI/2026/02/104367 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing the Effectiveness and Safety of Fentanyl and Dexmedetomidine Added to Spinal Anaesthesia for Pain Relief in Patients Undergoing Lower Abdominal Surgery |
|
Scientific Title of Study
|
A Randomized Comparative Study to Evaluate the Effects and Safety of Intrathecal Fentanyl Versus Intrathecal Dexmedetomidine as Adjuvants to 0.5 Percent Hyperbaric Levobupivacaine in Patients Undergoing Infraumbilical Surgeries Under Spinal Anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyam Gandhi |
| Designation |
Anaesthesia Resident |
| Affiliation |
MM Institute of Medical Sciences and Research Centre |
| Address |
Department Of Anaesthesia, MM Institute Of Medical Sciences And Research Centre, Mullana , Ambala
Haryana
133207
India
Department Of Anaesthesia,new building, 2nd floor, MM Institute Of Medical Sciences And Research Centre, Mullana , Ambala
Haryana
133207
India
Ambala
HARYANA
133207
India |
| Phone |
7600006468 |
| Fax |
|
| Email |
priyamgandhi1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sapna Bansal |
| Designation |
Professor and Head , Department of Anaesthesiology |
| Affiliation |
MM Institute of Medical Sciences and Research Centre |
| Address |
Department Of Anaesthesia, MM Institute Of Medical Sciences And Research Centre, Mullana , Ambala
Haryana
133207
India
Department Of Anaesthesia,2nd floor new building , MM Institute Of Medical Sciences And Research Centre, Mullana , Ambala
Haryana
133207
India
Ambala
HARYANA
133207
India |
| Phone |
8168381441 |
| Fax |
|
| Email |
hod.anaesthesia@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Sapna Bansal |
| Designation |
Professor and Head , Department of Anaesthesiology |
| Affiliation |
MM Institute of Medical Sciences and Research Centre |
| Address |
Department Of Anaesthesia, MM Institute Of Medical Sciences And Research Centre, Mullana , Ambala
Haryana
133207
India
Department Of Anaesthesia, 2nd floor new building, MM Institute Of Medical Sciences And Research Centre, Mullana , Ambala
Haryana
133207
India
HARYANA
133207
India |
| Phone |
8168381441 |
| Fax |
|
| Email |
hod.anaesthesia@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesia, MM Institute Of Medical Sciences And Research Centre, Mullana , Ambala
Haryana
|
|
|
Primary Sponsor
|
| Name |
Dr Sapna Bansal Professor and Head Department Of Anaesthesia |
| Address |
Department Of Anaesthesia, MM Institute Of Medical Sciences And Research Centre, Mullana , Ambala
Haryana
133207
India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyam Gandhi |
MM Institute Of Medical Sciences and Research Centre |
Department of Anaesthesiology , 2nd Floor , old building , MM Institute Of Medical Science And Research Centre, Mullana , Ambala, Haryana Ambala Haryana
Ambala
HARYANA |
7600006468
priyamgandhi1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee , MMIMSR, Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N201||Calculus of ureter, (2) ICD-10 Condition: S723||Fracture of shaft of femur, (3) ICD-10 Condition: S821||Fracture of upper end of tibia, (4) ICD-10 Condition: N70||Salpingitis and oophoritis, (5) ICD-10 Condition: I832||Varicose veins of lower extremities with both ulcer and inflammation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine + 0.5% Heavy Levobupivacaine |
Inj. Dexmedetomidine 5 mcg diluted upto 0.5ml with normal saline added to 3 ml of 0.5% heavy Levobupivacaine intrathecally |
| Comparator Agent |
Fentanyl + 0.5% Heavy Levobupivacaine |
Inj. Fentanyl 25 mcg added to 3 ml of 0.5% heavy Levobupivacaine intrathecally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age 18-60 years
2) American Society of Anesthesiologist physical status 1 or 2
3) Patients undergoing infraumbilical surgeries
|
|
| ExclusionCriteria |
| Details |
1. Negative consent by the patient
2. contraindication to spinal anaesthesia , (such as coagulopathy , infection at injection site , hypotension , disease or deformity of spine )
3. psychiatric patient
4.ASA status III/IV
5. known sensitivity to drug |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the onset, duration and highest level of sensory block along with degree and duration of motor block between two groups |
To study the onset, duration and highest level of sensory block along with degree and duration of motor block between two groups at different intervals, that is 0,2,4,6,8,10,15,20,25,30 minutes and post operative period upto 5hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the hemodynamic changes occuring among the two study groups after administration of the respective drugs
|
intraoperative period after spinal anaesthesia and post operative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized , double blind , pospective study is designed to evaluate the comparative effects and safety of adding fentanyl or dexmedetomidine to 0.5% hyperbaric levobupivacaine for spinal anaesthesia in patients undergoing infraumbilical surgeries . Spinal Anaesthesia involves the administration of local anesthetic directly into cerebrospinal fluid within the sub arachnoid space , producing reversible sensory and motor blockade . The distribution and height of the block are influenced by the density of the anesthetic solution relative to CSF, as well as patient positioning . hyperbaric solutions , creating by adding dextrose to levobupivacaine , are denser than CSF, allowing more predictable spread of anesthesia and better control over the block level. Levobupivacaine, the S enantiomer of bupivacaine , offers similar anesthetic potency with reduced cardiotoxicity and neurotoxicity compared to racemic bupivacaine , making it a safer option for spinal anaesthesia. To enhance the quality and duration of anesthesia, adjuvants like fentanyl , a lipophilic opioid, and dexmedetomidine , a selective alpha2- adrenergic agonist, can be added.Fentanyl provides rapid onset analgesia with minimal motor block, while dexmedetomidine prolongs sensory and motor blockade and may improve postoperative analgesia with stable hemodynamics. In this study , patient will receive either 5mcg demedetomidine or 25mcg fentanyl added to 3ml of 0.5percent hyperbaric levobupivacaine. The primary outcomes include the onset , duration and highest level of sensory block, as well as the degree and duration of motor block, while secondary outcomes include hemodynamic changes. The study aims to determine the superior adjuvant for providing safe, effective and prolonged spinal anaesthesia in infraumbilical surgeries |